ID

5024

Description

ODM derived from http://clinicaltrials.gov/show/NCT00875667

Link

http://clinicaltrials.gov/show/NCT00875667

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
Uploaded on

April 16, 2014

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility DRKS00003810 NCT00875667 Mantle Cell Lymphoma

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Biopsy proven mantle cell lymphoma
Description

Biopsy proven mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
C0334634
SNOMED CT 2011_0131
443487006
MedDRA 14.1
10061275
ICD-10-CM Version 2010
C83.1
ICD-9-CM Version 2011
200.4
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Patients who have progressed or relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease.
Description

Patients who have progressed or relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0242656
SNOMED CT 2011_0131
246453008
MedDRA 14.1
10061818
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1335499
ECOG performance score 0,1, or 2
Description

ECOG performance score 0,1, or 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
Willing to follow pregnancy precaution
Description

Willing to follow pregnancy precaution

Data type

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C1882442
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Abnormal Laboratory Test Result
Description

Any of the following laboratory abnormalities

Data type

boolean

Alias
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
Absolute Neutrophil Count, ANC
Description

Absolute neutrophil count (ANC)<1,500 cells/mm^3 (1.5 x 10^9/L)

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
Platelet count - finding
Description

Platelet count < 60,000/mm^3 (60 x 10^9/L)

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
Description

Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma

Data type

boolean

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0441932
SNOMED CT 2011_0131
258322007
UMLS CUI 2011AA
C0024299
SNOMED CT 2011_0131
21964009
MedDRA 14.1
10025310
ICD-10-CM Version 2010
C85.9
Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
Description

Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.

Data type

boolean

Alias
UMLS CUI 2011AA
C1278039
SNOMED CT 2011_0131
313840000
MedDRA 14.1
10040162
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0017551
SNOMED CT 2011_0131
27503000
MedDRA 14.1
10018267
ICD-10-CM Version 2010
E80.4
UMLS CUI 2011AA
C0441932
SNOMED CT 2011_0131
258322007
UMLS CUI 2011AA
C0024299
SNOMED CT 2011_0131
21964009
MedDRA 14.1
10025310
ICD-10-CM Version 2010
C85.9
Estimation of creatinine clearance by Cockcroft-Gault formula (procedure)
Description

Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min

Data type

boolean

Alias
UMLS CUI 2011AA
C2711451
SNOMED CT 2011_0131
442407001
History of active CNS lymphoma within the previous 3 months
Description

History of active CNS lymphoma within the previous 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0280803
SNOMED CT 2011_0131
307649006
MedDRA 14.1
10007953
ICD-9-CM Version 2011
200.5
Subjects not willing to take DVT prophylaxis
Description

Subjects not willing to take DVT prophylaxis

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0853245
MedDRA 14.1
10013880
Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
Description

Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible

Data type

boolean

Alias
UMLS CUI 2011AA
C0521143
SNOMED CT 2011_0131
4879001
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0042769
SNOMED CT 2011_0131
34014006
MedDRA 14.1
10047461
ICD-10-CM Version 2010
B34.9
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0019169
SNOMED CT 2011_0131
81665004
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0521143
SNOMED CT 2011_0131
4879001
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0062527
SNOMED CT 2011_0131
396424005
HL7 V3 2006_05
45
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Biopsy proven mantle cell lymphoma
Item
Biopsy proven mantle cell lymphoma
boolean
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C0334634 (UMLS CUI 2011AA)
443487006 (SNOMED CT 2011_0131)
10061275 (MedDRA 14.1)
C83.1 (ICD-10-CM Version 2010)
200.4 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Patients who have progressed or relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease.
Item
Patients who have progressed or relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease.
boolean
C0242656 (UMLS CUI 2011AA)
246453008 (SNOMED CT 2011_0131)
10061818 (MedDRA 14.1)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI 2011AA)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
ECOG performance score 0,1, or 2
Item
ECOG performance score 0,1, or 2
boolean
C1520224 (UMLS CUI 2011AA)
Willing to follow pregnancy precaution
Item
Willing to follow pregnancy precaution
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C1882442 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Any of the following laboratory abnormalities
Item
Abnormal Laboratory Test Result
boolean
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
Absolute neutrophil count (ANC)<1,500 cells/mm^3 (1.5 x 10^9/L)
Item
Absolute Neutrophil Count, ANC
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Platelet count < 60,000/mm^3 (60 x 10^9/L)
Item
Platelet count - finding
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
Item
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0441932 (UMLS CUI 2011AA)
258322007 (SNOMED CT 2011_0131)
C0024299 (UMLS CUI 2011AA)
21964009 (SNOMED CT 2011_0131)
10025310 (MedDRA 14.1)
C85.9 (ICD-10-CM Version 2010)
Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
Item
Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
boolean
C1278039 (UMLS CUI 2011AA)
313840000 (SNOMED CT 2011_0131)
10040162 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
C0441932 (UMLS CUI 2011AA)
258322007 (SNOMED CT 2011_0131)
C0024299 (UMLS CUI 2011AA)
21964009 (SNOMED CT 2011_0131)
10025310 (MedDRA 14.1)
C85.9 (ICD-10-CM Version 2010)
Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min
Item
Estimation of creatinine clearance by Cockcroft-Gault formula (procedure)
boolean
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
History of active CNS lymphoma within the previous 3 months
Item
History of active CNS lymphoma within the previous 3 months
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0280803 (UMLS CUI 2011AA)
307649006 (SNOMED CT 2011_0131)
10007953 (MedDRA 14.1)
200.5 (ICD-9-CM Version 2011)
Subjects not willing to take DVT prophylaxis
Item
Subjects not willing to take DVT prophylaxis
boolean
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0853245 (UMLS CUI 2011AA)
10013880 (MedDRA 14.1)
Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
Item
Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
boolean
C0521143 (UMLS CUI 2011AA)
4879001 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0521143 (UMLS CUI 2011AA)
4879001 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C0062527 (UMLS CUI 2011AA)
396424005 (SNOMED CT 2011_0131)
45 (HL7 V3 2006_05)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial